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Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01219465
Recruitment Status : Unknown
Verified September 2010 by Qingdao University.
Recruitment status was:  Active, not recruiting
First Posted : October 13, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetes Mellitus, Type 1 Mesenchymal Stem Cells Umbilical Cord Biological: umbilical cord mesenchymal stem cells Phase 1 Phase 2

Detailed Description:
Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes
Study Start Date : September 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: umbilical cord mesenchymal stem cells
Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells
Biological: umbilical cord mesenchymal stem cells
Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.
Other Name: mesenchymal stem cells


Outcome Measures

Primary Outcome Measures :
  1. C peptide release test [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Exogenous insulin dose [ Time Frame: 3 months ]
  2. blood glucose [ Time Frame: 3 months ]
  3. glycosylated Hemoglobin A1c [ Time Frame: 3 months ]
  4. Number of severe and documented hypoglycemic events [ Time Frame: 3 months ]
  5. Immunologic reconstitution parameters [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks.
  • Ability to provide written informed consent from patients or Child guardian.

Exclusion Criteria:

  • diabetic ketoacidosis.
  • evidence of retinopathy at baseline.
  • Body Mass Index >30.
  • Severe or acute organ damage.
  • Infectious diseases, e.g. HIV infection, or hepatitis B or C infection.
  • Severe psychiatric disorder.
  • Presence of malignancy.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219465


Locations
China, Shandong
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, China, 266003
Sponsors and Collaborators
Qingdao University
Investigators
Study Director: Yangang Wang, MD Phd The Affiliated Hospital of Medical College of Qingdao University
More Information

Responsible Party: Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
ClinicalTrials.gov Identifier: NCT01219465     History of Changes
Other Study ID Numbers: MSCT1DM003
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: September 2010

Keywords provided by Qingdao University:
Diabetes Mellitus
Diabetes Mellitus, Type 1
mesenchymal stem cells
Umbilical cord

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases